Adequate Hydration for Prevention of Contrast-Induced Nephropathy After Primary Percutaneous Coronary Intervention (RESCIND-STEMI)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Guangdong General Hospital
Sponsor:
Collaborators:
Peking University First Hospital
Chinese PLA General Hospital
Information provided by (Responsible Party):
Jiyan Chen, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT02067195
First received: February 16, 2014
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

To compare the efficacy of 2 different hydration strategies, hydration according to clinical guideline and adequate hydration, on contrast-induced nephropathy in patients with STEMI undergoing primary PCI to investigate the possible beneficial role of periprocedural adequate hydration.


Condition Intervention
ST Elevation Myocardial Infarction
Drug: Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride)
Drug: 3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Adequate Hydration for Prevention of Contrast-Induced Nephropathy After Primary Percutaneous Coronary Intervention, A Randomized, Controlled Trial REduction of riSk of Contrast-Induced Nephropathy After carDiac Catheterization -ST-Elevation Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Guangdong General Hospital:

Primary Outcome Measures:
  • Contrast-Induced Nephropathy [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    defined as a greater than 25% or an absolute increase of 0.5 mg/dl in serum creatinine over baseline during the first 48- 72 h post-procedure


Secondary Outcome Measures:
  • contrast-induced acute kidney injury [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    defined as a greater than 50% or an absolute increase of 0.3 mg/dl in serum creatinine over baseline during the first 48h post-procedure

  • Composite contrast-induced acute kidney injury [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Defined as an absolute increase of 0.3 mg/dl in serum creatinine over baseline during the first 48h post-procedure and as a greater than 10% in Cystatin C over baseline during the first 24h post-procedure

  • Persistent renal damage [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Defined as a residual impairment of renal function indicated by a reduction of creatinine clearance more than 25% at 3 months in comparison with baseline

  • Alteration of renal fuction [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    defined as the alteration of creatinine clearance and estimated glomerular filtration rate (GFR) by using Cystatin C over baseline during the first 48- 72 h post-procedure

  • Severe adverse renal events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Including contrast-induced nephropathy requiring renal replacement therapy and death caused by contrast-induced nephropathy

  • Major adverse cardiovascular events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Major adverse cardiovascular events included death, re- current myocardial infarction, repeated urgent revascularization


Estimated Enrollment: 500
Study Start Date: October 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Guideline Hydration
No hydration for patients without chronic kidney disease(CrCl<60ml/min),or Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride) after diagnosis of chronic kidney disease until 24 hours after PCI. Hydration rate was reduced to 0.5 mL/kg per hour in patients with New York Heart Association class III or KillipⅡ/Ⅲ.
Drug: Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride)
No hydration for patients without chronic kidney disease(CrCl<60ml/min),or Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride) after diagnosis of chronic kidney disease until 24 hours after PCI. Hydration rate was reduced to 0.5 mL/kg per hour in patients with New York Heart Association class III or KillipⅡ/Ⅲ.
Other Name: Guideline Hydration
Active Comparator: Adequate Hydration
Receiving hydration with a 3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride) from randomization to the end of the procedure, the measurement of LVEDP was conducted after the procedure, a sliding-scale hydration was employed in the LVEDP-guided hydration arm that was based on LVEDP for 2 hours: 5 ml/kg/hr for LVEDP <13 mmHg, 3 ml/kg/hr for LVEDP 13-18 mmHg, and >1.5 ml/kg/hr for LVEDP >18 mmHg, whereas,0.5 ml/kg/hr for LVEDP >20 mmHg, continue hydration with a 1 mL/kg until 24 hours after procedure. Hydration rate was reduced to 0.5 mL/kg per hour in patients with New York Heart Association class III or KillipⅡ/Ⅲ.
Drug: 3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride)
Receiving hydration with a 3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride) from randomization to the end of the procedure, the measurement of LVEDP was conducted after the procedure, a sliding-scale hydration was employed in the LVEDP-guided hydration arm that was based on LVEDP for 2 hours: 5 ml/kg/hr for LVEDP <13 mmHg, 3 ml/kg/hr for LVEDP 13-18 mmHg, and >1.5 ml/kg/hr for LVEDP >18 mmHg, whereas,0.5 ml/kg/hr for LVEDP >20 mmHg, continue hydration with a 1 mL/kg until 24 hours after procedure. Hydration rate was reduced to 0.5 mL/kg per hour in patients with New York Heart Association class III or KillipⅡ/Ⅲ.
Other Name: Adequate Hydration

Detailed Description:

all consecutive patients with STEMI,age at least 18 years, who were candidates for primary PCI at our institution were considered for enrollment in the present study. Initial exclusion criteria were contrast medium administration within the previous 14 days, end-stage renal failure requiring dialysis, and refusal to give informed consent. Eligible patients were randomly assigned in a 1:1 ratio to receive preprocedure and postprocedure hydration (adequate hydration group), hydration according to clinical guideline (guideline hydration group,control group )

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all consecutive patients with STEMI, age at least 18 years, who were candidates for primary PCI were considered for enrollment.

Exclusion Criteria:

  • contrast medium administration within the previous 14 days or follow 72 hours,
  • end-stage renal failure or renal transplantation, and refuse PCI or dead during the procedure,
  • heart failure of cardiac shock or New York Heart Association class IV,
  • recent acute kidney injury defined as an absolute increase of 0.5 mg/dl in serum creatinine over baseline in the past 24h
  • ,the presence of lactation, pregnancy,
  • malignant tumour or life expectancy less than 1 year,
  • allergy to contrast, peri-procedural receipt of metformin non-steroidalanti-inflammatory drugs in the past 48h and during the study period,
  • planned renal carthterization or heart valvular surgery。
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02067195

Contacts
Contact: Jiyan Chen, MD 86-20-83827812 ext 10528 chenjiyandr@126.com

Locations
China, Guangdong
Guangdong General Hospital Not yet recruiting
Guangzhou, Guangdong, China, 501080
Contact: Yong Liu, MD    86-20-83827812 ext 10528    liuyongyisheng@126.com   
Sponsors and Collaborators
Guangdong General Hospital
Peking University First Hospital
Chinese PLA General Hospital
Investigators
Principal Investigator: Jiyan Chen, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
Study Director: Yong Liu, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
  More Information

No publications provided

Responsible Party: Jiyan Chen, MD, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT02067195     History of Changes
Other Study ID Numbers: CSC20140222
Study First Received: February 16, 2014
Last Updated: February 19, 2014
Health Authority: China: Ethics Committee

Keywords provided by Guangdong General Hospital:
acute myocardial infarction,contrast,coronary intervention

Additional relevant MeSH terms:
Infarction
Kidney Diseases
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Urologic Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014